Introduction
The Shelf Life Rules in the importation of Medical Devices in India is of prime importance for every medical device manufacturer. In order to import into India, Manufacturers have to meet certain standards of quality and efficacy. The Import, Manufacturing, Distribution and Sale of Drugs, Cosmetics, Medical devices,and IVDs in the country is regulated under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and cosmetics Rules 1945. The Central Government monitors regulatory control over these articles imported in the country through the Central Drugs Standard Control Organisation (CDSCO) overlooked by the Drugs Controller India (DCG). All Medical Products imported in India need to get an No Objection Certificate (NOC) from the Assistant Drug Controller (ADC). The ADC can acquire the import permit of medical products as well. This article deals with the Shelf Life Rules of Medical Devices in India.
Shelf Life and Residual Shelf Life
Shelf life is the period during which the medical device remains suitable for the intended use. The term “shelf life” of a drug slightly differs from a drug’s “expiration date.” It generally relates to a drug’s quality over a specified period of time, whereas the expiration date is associated with both the quality and safety of a medication at a specific point in time. It is determined by labelling the product with a date mark. Residual shelf life is the period remaining, from the date upon delivery, to the expiry date, retest date, install by date or other use before date established by the supplier It also means the remaining length of time before the expiration date set forth in the applicable Product Specifications for the Product.
The shelf-life of drugs should only be considered valid, if the product is purchased intact and undamaged. End-Users have to ensure to always follow manufacturers’ instructions on storage, particularly temperature and use of the product after opening. It only refers to the period for which they can be used while maintaining the quality. Extrinsic factors, such as gaseous atmosphere, storage temperature, and relative humidity coupled with intrinsic properties of the drug determine the shelf stability and perishability of the item.
How is COVID Impacting Shelf Life of Medical Products
The pandemic has disrupted global distribution and has created extreme challenges in the importation of Medical Devices. Increased border controls and regulations in customs has resulted in longer wait times and lack of capacity for long-haul and last-mile fulfillment creating extreme challenges for the Medical Device Industry. Moreover, it is a big concern for raw material manufacturers as there is a disruption in the supply chain with the non-availability of fresh material. This is hampering the delivery of imported products and considerable delays in reaching consumers. Various consignments have been stuck due to several issues related to logistics, manpower and restrictions on movement.
Previous Shelf Life Rules
Prior to COVID-19, as per Rule 31 of the Drugs and Cosmetics Rules, 1945, no drug shall be imported unless it complies with the standard of strength, quality and purity. The licensing authority can not allow any drug with less than 60% residual shelf-life period to be imported into India, however it will consider exceptions to the rule in the following circumstances:
- For charity purposes
- For drugs required in emergency situations
- Drugs required for the treatment of diseases originated in India
- Drugs imported for testing purposes
- Orphan drugs for rare diseases
- Drugs required for sudden outbreak of diseases
- Drugs for manufacturing of formulation exclusively for export
New Shelf Life Rule
Due to the various delays in delivering of Medical Products to end users, the CDSCO has issued a special Condition under which the permission for import of Drug with residual Shelf Life less than 60% is allowed. This timeline has been extended upto the 30th April, 2021. This is a temporary law which has been passed to ease the movement of goods. However, The DCGI’s letter informs that importers give an undertaking that the drug/s would be utilised or consumed before the expiry date. The licensing authority will not allow the import of a medical device with a less than 60% residual shelf life as on the date of import. In certain exceptional cases, the licensing authority may, for reasons to be recorded in writing, allow the import of any drug with a lesser shelf life, but before its expiry.
Conclusion
In conclusion, it is important to understand the mode of deterioration in order to establish any particular product’s shelf life. The shelf life of commercial products should be monitored and adjusted as required. In determining shelf life of medical device manufacturers must consider both degradation of the sterile barrier system as well as the product itself. Every importer must be aware of these rules and adhere to them during the importation process. Any deviation from the guidelines, could cause a further delay in the availability of Medical Devices to the end- users as they would not be allowed to clear customs.
How can Morulaa Help?
Morulaa HealthTech as successful regulatory and import consultants, has delivered high levels of professionalism and towards our clients. To understand how the Shelf Life of your Medical Products will affect your business in India, contact us to know more.